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Table 2 Summary of TEAEs and all-cause mortality by treatment group

From: Safety and effectiveness of taliglucerase alfa in patients with Gaucher disease: an interim analysis of real-world data from a multinational drug registry (TALIAS)

 

Treatment-naïve group (n = 8)

Prior ERT group (n = 93)

Prior ERT and SRT group (n = 5)a

Total patients (N = 106)

Total TEAEs, n

15

78

2

95

Total treatment-related TEAEs, n

1

20

0

21

Patients with TEAEs, n (%)

4 (50.0)

34 (36.6)

1 (20.0)

39 (36.8)

Patients with treatment-related TEAEs, n (%)

1 (12.5)

11 (11.8)

0 (0.0)

12 (11.3)

Patients with SAEs, n (%)

1 (12.5)

10 (10.8)

1 (20.0)

12 (11.3)

Patients with treatment-related SAEs, n (%)

0 (0.0)

2 (2.2)

0 (0.0)

2 (1.9)

Patients with severe TEAEs

1 (12.5)

6 (6.5)

1 (20.0)

8 (7.5)

Patients with treatment-related severe TEAEs

0 (0.0)

2 (2.2)

0 (0.0)

2 (1.9)

Patients with discontinuations due to TEAEsb, n (%)

0 (0.0)

4 (4.3)

0 (0.0)

4 (3.8)

Patients with all-cause mortality, n (%)

0 (0.0)

4 (4.3)

0 (0.0)

4 (3.8)

  1. ERT enzyme replacement therapy; SAEs serious adverse events; SRT substrate reduction therapy; TEAEs treatment-emergent adverse events
  2. aOne patient was reported under the “Prior ERT and SRT” group due to erroneous recording of some ERTs as SRTs in the study database
  3. bThe number of patients who discontinued due to all causality TEAEs are same as the ones due to treatment-related TEAEs